FDA Product Code JIT: Calibrator, Secondary
Leading manufacturers include Dade Behring, Inc., Wako Chemicals USA, Inc. and Roche Diagnostics Corp..
245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
Cleared
Oct 28, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
Roche Diagnostics
Chemistry
4d
Cleared
Oct 03, 2005
ISE COMPENSATOR
Roche Diagnostics
Chemistry
53d
Cleared
Aug 22, 2005
IRON STANDARD
Roche Diagnostics Corp.
Chemistry
28d
Cleared
Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
Roche Diagnostics Corp.
Immunology
161d
Cleared
Dec 09, 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
Ortho-Clinical Diagnostics, Inc.
Chemistry
56d
Cleared
Dec 03, 2004
OLYMPUS LACTATE, OSR6193
Olympus America, Inc.
Chemistry
91d
Cleared
Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
Roche Diagnostics Corp.
Immunology
14d
Cleared
Nov 18, 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
Ortho-Clinical Diagnostics, Inc.
Chemistry
63d
Cleared
Oct 05, 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Beckman Coulter, Inc.
Toxicology
7d
Cleared
Sep 30, 2004
ELECSYS FOLATE II CALSET II
Roche Diagnostics Corp.
Chemistry
16d
Cleared
Apr 23, 2004
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
Wako Chemicals USA, Inc.
Chemistry
133d
Cleared
Apr 08, 2004
OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023
Olympus America, Inc.
Chemistry
22d
Cleared
Mar 25, 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
Wako Chemicals USA, Inc.
Chemistry
52d
Cleared
Mar 10, 2004
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296
Olympus America, Inc.
Chemistry
15d
Cleared
Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
Abbott Laboratories
Chemistry
56d
Cleared
Aug 21, 2003
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
Olympus America, Inc.
Chemistry
28d
Cleared
Aug 07, 2003
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
Ortho-Clinical Diagnostics
Chemistry
45d
Cleared
May 12, 2003
ELECSYS LH CALSET II
Roche Diagnostics Corp.
Chemistry
18d
Cleared
Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
Dade Behring, Inc.
Immunology
87d
Cleared
May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
Dade Behring, Inc.
Chemistry
63d
Cleared
Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
Beckman Coulter, Inc.
Chemistry
48d
Cleared
Oct 09, 2001
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
Nichols Institute Diagnostics
Chemistry
75d
Cleared
Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
Dade Behring, Inc.
Chemistry
57d
Cleared
Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
Roche Diagnostics Corp.
Chemistry
28d